The Recall Desk
ModerateFDA (Devices)·Z-0831-2018·Announced 2018-03-07

Cook Percutaneous Gastrojejunostomy Set Recalled for Backwards Wire Guides

Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets because wire guides may be loaded backwards into the holder.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cook Inc. is recalling Percutaneous Gastrojejunostomy Sets intended for the percutaneous placement of a catheter for gastroenteric feeding. The recall was initiated because the company identified that affected lots may contain wire guides that were loaded backwards into the wire guide holder.

The affected product is distributed nationwide in the United States. The specific lot number is NS7587941, with code WOGS-1200-WH- 050493. Quantities are co-mingled into line 1.

Healthcare providers and patients should check their inventory and usage records for this specific lot number. If the product has been used or is in inventory, it should be stopped and returned to the manufacturer or distributor for further instructions.

The recalled product

Product
Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percutaneous placement of a catheter for gastroenteric feeding
Manufacturer
Cook Inc.
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • WOGS-1200-WH- 050493 Lot number: NS7587941

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →